Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00371

2 Trial Registration Date

2013-06-14

i Registration Status

Prospective

3 Secondary IDs

CRE-2012.514-T

4 Source(s) of Funding

NA

5 Primary Sponsor

Division of Neurology, Department of Medicine & Therapeutics, The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Eva JY LIU

ii Address

Division of Neurology, Dept of Medicine and Therapeutics,PWH

iii Phone

2632 1853

iv Email

evajyliu413@gmail.com

v Affiliation

Division of Neurology, Dept of Medicine and Therapeutics,PWH,CUHK

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Ka Sing WONG

ii Address

Division of Neurology, Dept of Medicine and Therapeutics，PWH

iii Phone

2632 3877

iv Email

ks-wong@cuhk.edu.hk

v Affiliation

Dept of Medicine and Therapeutics, PWH,CUHK

vi Country

9 Official Scientific Title of the Study

A randomized controlled trial of transcranial magnetic stimulation
and robotic-hand therapy to improve hand function after ischemic stroke

10 Public Title

A randomized controlled trial of transcranial magnetic stimulation
and robotic-hand therapy to improve hand function after ischemic stroke

i Public Title in Chinese 研究名稱

機械手及經顱磁刺激聯合療法對中風病人手部運動功能康復的研究

11 Short Title (Optional)

TBS-ROBOT

12 Countries of Recruitment

HK, CHINA

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2013-01-22

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

stroke

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

transcranial magnetic stimulation &
robotic-hand therapy

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

10 sessions for TBS ,20 sessions for robotic-hand therapy

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

sham transcranial magnetic stimulation

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

1) patients aged 18 or above; 2) first-ever ischemic subcortical stroke with onset time less than 21 days; 3) hand weakness as a result of stroke; 4) intracerebral hemorrhage excluded by brain computed tomography (CT) / magnetic resonance imaging (MRI) ; 5) the patient or his/her legally acceptable representative is willing to provide written informed consent.

ii Exclusion Criteria

1) personal history of epilepsy; 2) metallic implants in any part of body; 3) implanted cardiac pacemaker, defibrillator, medication pump or any other implanted electronics; 4) severe skull fracture, serious head injury, history of brain or spinal cord surgery; 5) brain tumour or other significant non-ischemic brain lesion on CT/MRI; 6) administration of drugs that potentially lower seizure threshold; 7) severe hand spasticity, open hand wound or hand deformity; 8) history of malignancy; 9) severe co-existing systemic diseases, severe dementia or psychosis; 10) inability to be followed up at regular interval; 11) pregnancy or breast-feeding

iii Age Minimum

18

iv Age Maximum

90

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2013-07-01

21 Target Sample Size

63

22 Recruitment Status

Suspended

23 Primary Outcome

Upper limb fugl-meyer assessment (FMA)at week 12 after stroke

24 Secondary Outcome

RMT, AMT, MEP, S/R curve, Power Grip, Lateral Pinch Grip, Purdue Pegboard for both hands ,NIHSS,mRS at baseline,week 4, week 8, week 12, week 24 after stroke.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2017-04-25

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-13003417

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

NA

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Trial History Detail on 2014-06-16